Optimization of a mHealth Physical Activity Promotion Intervention With Mindful Awareness for AYAO (OPT2MOVE)

Cancer Clinical Trial

Official title: Optimization of a mHealth Physical Activity Promotion Intervention With Mindful Awareness for Adolescent and Young Adult Cancer Survivors

Status Recruiting

Clinical Trial Summary

The purpose of the present study is to utilize Multiphase Optimization Strategy (MOST)1 to test four social support and mindfulness components (e-coaching, buddy, general mindfulness training, and MVPA-specific mindfulness training) in a 12-week mHealth moderate to vigorous intensity physical activity (MVPA) intervention in a sample of young adult cancer survivors (YACS), to improve quality of life (QOL) and decrease adverse effects and symptom burden.

PRIMARY AIM To identify which components from four mHealth components under consideration for inclusion meaningfully contribute to improvements in MVPA at 12 and 24 weeks

SECONDARY AIM To examine how changes in MVPA, as a result of Opt2Move components, may influence additional health behaviors and outcomes including: a) symptom burden (i.e. fatigue, depression, anxiety); b) time spent in other activity intensities (i.e. light, sedentary time); and c) sleep duration and quality

THIRD AIM To examine potential mediators (i.e. adherence, psychosocial factors such as post-traumatic growth, self-compassion, self-efficacy, and goal setting) and moderators (cancer type, age, gender) of the four intervention components on MVPA.

Clinical Trial Description

The purpose of the present study is to utilize Multiphase Optimization Strategy (MOST)1 to test four social support and mindfulness components (e-coaching, buddy, general mindfulness training, and MVPA-specific mindfulness training) in a 12-week mHealth moderate to vigorous intensity physical activity (MVPA) intervention in a sample of young adult cancer survivors (YACS), to improve quality of life (QOL) and decrease adverse effects and symptom burden.

PRIMARY AIM To identify which components from four mHealth components under consideration for inclusion meaningfully contribute to improvements in MVPA at 12 and 24 weeks

SECONDARY AIM To examine how changes in MVPA, as a result of Opt2Move components, may influence additional health behaviors and outcomes including: a) symptom burden (i.e. fatigue, depression, anxiety); b) time spent in other activity intensities (i.e. light, sedentary time); and c) sleep duration and quality

THIRD AIM To examine potential mediators (i.e. adherence, psychosocial factors such as post-traumatic growth, self-compassion, self-efficacy, and goal setting) and moderators (cancer type, age, gender) of the four intervention components on MVPA.

Research participants will be identified and recruited at Robert H. Lurie Cancer Center (RHLCC) at Northwestern University (NU) and at the Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) at Wake Forest University (WFU). All YACS and Buddies will complete an initial 10-15 minute eligibility screening online, over the phone, or in-person. The study RA will obtain informed consent and HIPAA authorization from eligible participants according to IRB approved procedures. After consent is received, all additional study procedures (i.e. assessments, orientation, intervention delivery, etc.) will be handled by the coordinating center (NU) to ensure all procedures are implemented consistently and improve efficiency.

Assessments. After informed consent completion, the NU study team will send participants an email with an individual, secure link to study questionnaires and notification that an ActiGraph accelerometer packet has been mailed. Participants will be asked to complete the questionnaire within 1 week of receipt. YACS will be provided with detailed written instructions for how to wear the ActiGraph.

Randomization and Study Orientation. After completing baseline assessments, YACS (n=304) will be randomized to each group using computer-generated randomly permuted blocks. After randomization, the NU study team will send the participant an intervention packet which will include the Fitbit, Fitbit instructions, instructions and a QR code to download the Opt2Move app, and instructions specific to each condition to which they are assigned. The participant will also be scheduled for an orientation phone or web call with study staff to go over the contents of the intervention packet and expectations of participation for each component in greater detail.

Intervention Components

Core Intervention (Fitbit + Opt2Move App). All participants will receive a low-resource self-monitoring intervention consisting of the Fitbit AltaHR (or similar) and the Opt2Move self-monitoring app. Participants will be asked to download the Fitbit app and wear the Fitbit 24/7 throughout the 24-week study period. The core OPTIMAL AYAO app will support YACS to increase their MVPA. Participants will be provided with a weekly MVPA goal to build efficacy and ensure safe progression towards the overall goal of 150 minutes per week. Participants will be instructed to self-monitor progress towards these goals via feedback on Fitbit Alta HR and the daily, weekly and monthly progress information provided in the Opt2Move app.

Buddy. Participants assigned to this condition will select a buddy of their choice (i.e. friend, co-worker, caregiver or family member) that is ≥ 18 years of age and willing to share their Fitbit data with the study team. The study team will reach out to the buddy via an email containing a description of the expectations of the buddy and a link to complete online screening. The buddy will be mailed a Fitbit, share their Fitbit data with the study team, and be provided with access to, and instructions for, all of the Opt2Move app modules the participant has access to for their assigned condition. The buddy will be expected to attend a 15-30 minute group orientation call and listen to four 10-15 minute podcasts (one every 3 weeks) during the 12 week intervention. Each podcast will provide social support training and peer discussion of challenges and successes in providing YACS with MVPA support.

E-coaching. Participants assigned to this condition will receive a weekly scheduled text message from their coach. Text messages will focus on building self-efficacy and self-regulation skills, setting realistic outcome expectations, overcoming barriers, and problem-solving and will directly support the participant's engagement in the intervention. The coach will provide a brief overview of the participant's recent progress and goals, ask if they are having any barriers and help them troubleshoot and set specific goals for the next week. In addition to the scheduled messaging, participants will also be instructed to reach out to their coach with any questions or for additional assistance. The coach will respond within 24 hours (weekdays) to 48 hours (weekends), maximum.

General Mindfulness Training. Participants assigned to this condition will be instructed to watch 1 (1-2 mins), mindfulness education videos each week which lay the foundation for what mindfulness is and how it can be an important health behavior. Each week participants will also be asked to listen to general guided mindfulness audio files ≥5 days/ week. The length of recordings will gradually increase each week from 3-5 to 25-30 minutes. All videos and recording will be available via the Opt2Move app.

MVPA-Specific Mindfulness Training. Participants assigned to the MVPA-specific mindfulness training component will be instructed to watch 1-2 brief (1-2 minute), mindfulness education videos each week which lay the foundation for what mindfulness is and the importance of linking mindful awareness with MVPA. Each week participants will be provided access to MVPA-specific guided mindfulness audio files (e.g., 10-minute treadmill walking meditation, 20-minute bicycling meditation) that they will be asked to listen to during ≥3 MVPA sessions/week. The length and intensity of these audio files will correspond to their progression in the program. All videos and recording will be accessed via the Opt2Move app.

Follow-up. Participants will be instructed to maintain their MVPA during the 12-week follow-up period. They will have access to all materials to which they were assigned to less any direct contact from the study team. ;

Related Conditions & MeSH terms

• Cancer

• NCT number: NCT05375162
• Study type: Interventional
• Source: Northwestern University
• Contact: Siobhan M Phillips, PhD, MPH
• Phone: 312-503-4235
• Email: smphillips@northwestern.edu
• Status: Recruiting
• Phase: N/A
• Start date: July 18, 2023
• Completion date: December 31, 2025